Tuesday, May 26, 2009

Who had the Seed Strain and how did GlaxoSmithKline Get the Orders

Questions should be asked on why GlaxoSmithKline was picked to supply the orders for the H1N1 vaccine.

The only news report that the seed strain was given to anyone, was in the WSJ, on May 19th to Novartis.

And on their web site they state:

Novartis has begun aggressive efforts to develop an H1N1 vaccine. We intend to use both cell-based which is potentially faster, and egg-based production methods to increase the likelihood of the greatest possible supply. Novartis has received the genetic code of the new H1N1 virus strain, and the wild virus strain. Our intention is to be in a position to manufacture a vaccine as quickly as possible.

On May 20th, on PBS, Sanofi Pasteur, was still waiting for the strain.

But on May 15th, 2009, it was GlaxoSmithKline that gets the big contracts for manufacturing the virus, but there are no reports of it getting the seed strain in the news.

I will play the devil's advocate here.

The question should be asked why would they get the vaccine orders, if Glaxo does not have the seed strain. Wouldn't it stand to reason that the company that has the best chance to manufacture the vaccine the quickest, be the one to get the orders?

WASHINGTON (AP) — Inching closer to a swine flu vaccine, the government is beginning to analyze two candidates for the key ingredient to brew one. The Centers for Disease Control and Prevention hopes to deliver one or both to vaccine manufacturers by the end of next week so scientists can begin the months-long process of producing shots.

BETTY ANN BOWSER: Here, at Sanofi Pasteur in Swiftwater, Pa., the world's largest manufacturer of influenza vaccine, the company's labs are now waiting for the arrival of an H1N1 seed strain from the Centers for Disease Control in Atlanta.

It's one of seven labs around the world racing to find the key ingredient: the seed strain, which is an actual sample of a virus, that is used to develop a vaccine.

PHIL HOSBACH, vice president, Sanofi Pasteur: We're prepared. We're ready to go. We're still waiting for that seed virus. And once someone tells us what our role and responsibility is, we can begin the manufacturing process, shortly after receiving that seed virus.

The vaccine process begins with the viral isolate being converted into “seed stock.” CDC has already sent five isolates to seven laboratories to make this starting material. A key property of seed stock is that it’s a weakened, or attenuated, version of the original virus, which makes for a safer production process and lowers the risk of an accidental release.

Skinner says CDC expects to have the seed stock in hand next week. According to the WHO report, it will then take 1 to 2 weeks of testing in animals to make sure that the seed stock is properly attenuated. But Skinner says CDC will simultaneously conduct these animal tests and send the seed stock to some manufacturers that have biosafety level 3-plus laboratories (BSL-3 plus), which are specially designed to work with dangerous pathogens. “Those that have the BSL-3 plus labs, and some do, will start right away,” says Skinner, who stresses that, in the United States, all of this depends on the government deciding to procure the vaccine, which has not happened yet.

Meanwhile, Novartis said today that it has received a seed strain of H1N1designed to be used in the vaccine manufacturing process, according to AFP, and GlaxoSmithKline said it has received orders from several governments for tens of millions of doses of H1N1 vaccine, Dow Jones Newswires says.

The seed strain, or starting material for the new virus which is being grown at the U.S. Centers for Disease Control and Prevention (CDC) and other laboratories, will be given to manufacturers by mid- to late-May, she said.

"We have no doubt making a successful vaccine is possible within a reasonably short period of time," Kieny told a news conference.